Novo Nordisk US

Senior Manager, FP Process & Compliance

Novo Nordisk US$108K — $130K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering, Science, Business, or related field; MS preferred.
  • 5-7 years of leadership/management experience in Manufacturing or Quality, preferably in pharmaceutical or related industries.
  • In-depth knowledge of packaging and device assembly processes, including SAP, Pas-X, and Serialization.
  • Familiarity with Quality Management System, Lean, and/or Six Sigma methodologies.
  • Demonstrated history of implementing sustainable process improvements.
  • Expertise in planning, organizing, and managing execution to meet strategic objectives.

Responsibilities

  • Lead process and compliance improvement initiatives within Finished Production.
  • Coach and mentor direct reports according to company principles.
  • Develop long-term process and quality improvement plans.
  • Establish and champion clear quality standards and expectations.
  • Ensure quality process performance aligns with business and customer demands.
  • Coordinate Quality Event Communication and Containment processes.
  • Identify and prioritize compliance improvement projects based on trend analysis.

Benefits

  • Opportunity for professional development and growth through individual development plans.
  • Exposure to global best practices and contributions across manufacturing compliance.
  • Engagement in mentorship and leadership training programs.
  • Supportive open office environment fostering collaboration.
  • Potential for travel to enhance work experience and networking.
Full Job Description
The Position

Lead tactical and long-term strategic activities to drive process and compliance improvement within FP and ensure process and quality robustness and standardization across shift teams.

Relationships

Reports to Director, Finished Production.

Essential Functions
  • Coaching and mentoring of direct reports in accordance with the NNWay essentials
  • Development of long term process and quality improvement plans
  • Champion creation of simple and robust Quality standards and expectations
  • Drive quality process performance to meet business and customer needs
  • Championing the Quality Event Communication and Containment processes
  • Process confirmation and continuous improvement of NC Process within FP and compliance standards
  • Identify trends proactively to drive and prioritize compliance improvement projects and initiatives
  • Drive departmental Quality Steering Group agendas
  • Process Group Responsibilities (non-Technical) representing the Clayton site and contributing globally to better / best practices and projects for manufacturing compliance and robustness
  • Audit team coordination and development of audit standards / practices
  • Ownership of FP APR coordination
  • Ownership of FP Customer complaint coordination
  • Ownership of procedural support for PS[redacted], Pas-X, and Serialization. Establishment of departmental roles and responsibilities for these systems
  • Other accountabilities as assigned


Physical Requirements

Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% of the time. (% can change on a case-by-case basis based on the role.)

Development of People

Supervisory. Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process. Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility. Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.

Qualifications
  • Bachelor's Degree in Engineering, Science, Business or related field. MS preferred or industry equivalent experience preferred
  • Minimum 5-7 yrs. leadership / management experience in Manufacturing or Quality with a preference toward pharmaceutical or other related industries preferred
  • In depth knowledge of packaging and device assembly processes and supporting systems (SAP, Pas-X, Serialization) preferred
  • Knowledgeable in Quality Management System, Lean and / or Six Sigma methodologies preferred
  • Proven track record of implementing sustainable process improvements preferred
  • Proven expertise in planning / organizing, managing execution, checking results, and revising strategic plans to ensure short and long term objectives are met preferred

About Novo Nordisk US

Novo Nordisk is a global healthcare company that specializes in diabetes care and other chronic diseases. The company was founded in Denmark in 1923 and has since expanded to become a leading provider of insulin and other diabetes treatments. Novo Nordisk operates in more than 80 countries and employs over 43,000 people worldwide. The company is committed to improving the lives of people with diabetes and other chronic conditions through innovative research, development, and manufacturing of pharmaceutical products. Novo Nordisk US is headquartered in Plainsboro, New Jersey and has facilities in several other states including North Carolina and New Hampshire.
Learn more about Novo Nordisk US
Size
49,295 employees
Market Cap
$230.5 billion
Industry
Net Income
$42.1 billion
Founded
1923
5 Year Trend
+4.7%
Revenue
$126.9 billion
NASDAQ

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